Truenat® COVID-19
Manufactured by Molbio Diagnostics Private Limited, India - https://www.molbiodiagnostics.com/
Device identification number
2913
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Near POC / POC
Physical Support
Biochip, Chip
Target type
Nucleic acid
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Truenat® COVID-19 is a chip-based Real Time duplex Reverse Transcription Polymerase Chain Reaction (RT PCR) test for the semi quantitative detection of SARS CoV-2 RNA in human oropharyngeal and nasopharyngeal swab specimen and aids in detection and confirmation of SARS CoV-2 infection and diagnosis of COVID-19. The test detects the E and Orf1a genes of the virus. Truenat® COVID-19 runs on Real Time Quantitative micro PCR Analyzers.
Assay Type
Nucleic acid-PCR
Self Test
No
Reader Required
No
Method
RT-PCR
Measurement
Semiquantitative
Time
45 minutes
LOD
480 copies/ml (Orf1a (with 95% CI interval of 410 - 628))
LOD
487 copies/ml (E gene (with 95% CI interval of 419-631))
Analytical Sensitivity
100
Analytical Specificity
100
Clinical Sensitivity
100
Clinical Specificity
100
Throughput
other
The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements